NCT06298838Not yet recruiting
High-resolution Intra-operative PSMA PET-CT in Prostate Cancer
Perioperative Assessment of Intraoperative Margins and Lymph Node Invasion Using High-resolution 18F-PSMA-PET-CT in Prostate Cancer: a Pilot Study
Source: ClinicalTrials.gov · Last updated 18 May 2026
Brief summary (registry, in English)
This is a Single-center, diagnostic open-label prospective, pilot study in a total of 10 patients affected by Prostate cancer (PCa) with a risk of lymph node invasion (LNI) higher than 5% and candidates for a robot-assisted radical prostatectomy (RARP) with an extended pelvic lymph node dissection (ePLND) . The aim of the trial is to evaluate the feasibility and accuracy and clinical value of a novel high-resolution perioperative PET-CT-scan for intraoperative margin and lymph node invasion assessment, after 18F-PSMA injection, using histopathology as the gold standard.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 10 (estimated)
- First submitted
- 20 Feb 2024
- Start date
- Jun 2026
- Primary completion date
- May 2027
- Lead sponsor
- IRCCS San Raffaele
- Diseases
- Prostate cancer
- NCT number
- NCT06298838
What you commit to
- Study type: Observational
- Planned participants: 10
- From Jun 2026 to the primary completion date, May 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient previously received radiotherapy of the prostate.
- Patient participated in other clinical studies with radiation exposure of more than 1 mSv in the past year.
Other illness
- Patient has active viral or fungal infection.
Other
- Patient has general or local contra-indications for radical prostatectomy.
Who the study is looking for
- Male patient, 18 years of age or older.
- Patient is confirmed with high risk prostate cancer.
- Patient is indicated to undergo radical prostatectomy and ePLND.
- Patient is estimated compliant for study participation by the investigator.
- Patient has freely given his/her informed consent to participate in this study.
Age in the registry: 18 years to 80 years · Sex: Male · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.